The FDA Law Blog

OCTOBER 3, 2022

Mr. Bawduniak alleged that, between 2009 and 2014, Biogen paid illegal kickbacks to its largest prescribers to induce them to prescribe the company’s multiple sclerosis drugs, Avonex, Tysabri and Tecfidera, and discourage them from prescribing newer competitor products. This lawsuit was brought to the U.S. See United States ex rel.

Documentation 105

Documentation 105

ISPE

FEBRUARY 14, 2023

After a thorough internal review, health authorities sometime release a document for public comment. Regulations, draft guidance, and other documents may be requested for public comment. ISPE utilizes its members' expertise and knowledge to provide official comments on government documents. Know the key topics.

Documentation 52

Documentation Communication 52

pharmaphorum

DECEMBER 22, 2021

The document also states the importance of real-world data in understanding how currently available pharmaceutical products work in different populations. 536/2014, sponsors must submit a lay summary no later than 12 months after the protocol-defined end of the study. Under EU regulation No. Looking ahead.

Documentation 105

Documentation 105

Pharmaceutical Technology

JANUARY 6, 2023

The agreement outlined that Par would keep its generic equivalent off the market for as many as two years, delaying the generic launch till September 30, 2014. This class-action litigation specifically focused on a 2011 licensing agreement between the two companies. These actions allegedly led to the extension of Novartis’ patents.

Documentation 97

Documentation FDA Hospitals Dosage 97

ISPE

SEPTEMBER 8, 2023

The ISPE Drug Shortages Team developed the model as a follow-up to the ISPE Drug Shortages Prevention Plan that was released in 2014. This article outlines these initiatives. The model provides expanded guidance that reflects the new insight and best practices that have emerged in the past several years. What do you love about your job?

Documentation 91

Documentation 91

Omnicell

JANUARY 10, 2023

The investigation, which included inquiries requesting large amounts of documents and communications from various stakeholders, is largely perceived as a drug industry-friendly fact-finding exercise. 2014: HRSA considered publishing a regulation that would have narrowed the definition of patient and placed other restrictions on the program.

Hospitals 96

Hospitals Omnicell Insurance Documentation 96

Impact Pharmaceutical Services

AUGUST 9, 2022

Over the next year, IMPACT authored the following documents for the client: Pre-NDA meeting package. Working with the company’s electronic publishing vendor to ensure that fully-compiled, submission-ready documents were produced. 5 clinical study reports. and 2.7.4), and the Clinical Overview (Module 2.5).

Documentation 40

Documentation FDA Packaging Labelling 40

Impact Pharmaceutical Services

AUGUST 9, 2022

Over the next year, IMPACT authored the following documents for the client: Pre-NDA meeting package. Working with the company’s electronic publishing vendor to ensure that fully-compiled, submission-ready documents were produced. 5 clinical study reports. and 2.7.4), and the Clinical Overview (Module 2.5).

Documentation 40

Documentation FDA Packaging Labelling 40

pharmaphorum

DECEMBER 29, 2022

The case revolves around allegations that Novartis made an agreement in 2011 with Par Pharmaceutical when Exforge (valsartan/amlodipine) was nearing the end of its patent life that was designed to keep Par’s generic version of the drug off the market until 30 September, 2014.

Specialty Pharmacies 52

Specialty Pharmacies Documentation FDA 52

pharmaphorum

FEBRUARY 9, 2021

It makes for an agreement which is neither a legal document nor a policy one. 192 companies were members of the VPAS in 2019 versus 175 in the previous deal, the 2014 Pharmaceutical Price Regulation Scheme (PPRS). In the old days of the PPRS there were annual reports to Parliament (the last one found dates from 2014 ).

Documentation 87

Documentation 87

Pharmaceutical Technology

MARCH 30, 2023

Broadening uses and secured full approvals Since its first approval in September 2014, Keytruda has achieved blockbuster status on the market. There, the FDA suggested that the drugs undergo randomised controlled trials, which the document describes as the preferred approach, rather than single-arm trials.

Chemotherapy 52

Chemotherapy Packaging FDA Documentation 52

Impact Pharmaceutical Services

MAY 4, 2022

In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions. Image courtesy of qimono at pixabay.com.

FDA 52

FDA Documentation Communication 52

Pharmaceutical Technology

OCTOBER 5, 2022

Between 2009 and 2014, the time period of Biogen’s alleged misconduct, the standard of care for MS involved the use of Biogen’s immunomodulatory drugs such as Avonex (Interferon beta-1a), Tecfidera (dimethyl fumarate), and Tysabri (natalizumab).

Documentation 59

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 59

European Pharmaceutical Review

JULY 13, 2023

5 When these medicines are prescribed to patients, we can use feedback from the real-world data that documents clinical outcomes, efficacy measures, patient-reported outcomes, and adverse events. 2014 Jan;32(1):40-51. British journal of pharmacology. 2005 Dec;146(7):913-5. Hay M, Thomas DW, Craighead JL, et al. Nature biotechnology.

Compounding 98

Compounding Documentation Insurance Immunization 98

European Pharmaceutical Review

DECEMBER 20, 2023

In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents. Figure 2: European Commission proposed changes to regulatory data protection periods for non-orphan and orphan drugs (Source: L.E.K) What are the latest amendments?

Labelling 98

Labelling Documentation 98

Druggist

FEBRUARY 17, 2021

The mechanism action of local anaesthetic creams is well defined, and their effectiveness well documented. Crotamiton was also found to (weakly) affect serotonin release, another compound which has its role in the transfer of the information (about itchiness) to the brain (Saltsman, 2014). Saltsman Kirstie (2014). NICE (2020).

Compounding 98

Compounding Documentation Labelling 98

Pharmaceutical Technology

SEPTEMBER 26, 2022

Given the conflict present in the eastern part of Ukraine from 2014, sponsors, investigators and logistics providers were prepared for potential disruption. CROs and sponsors use remote source document verification, as approved by the regulator pre-war. Using technology and decentralisation has also contributed.

Packaging 52

Packaging Documentation 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2.

Documentation 52

Documentation Dosage Packaging Communication 52

Impact Pharmaceutical Services

AUGUST 9, 2022

Hosted software to publish regulatory submissions in the electronic common technical document (eCTD) format was deployed. By early 2014, the Regulatory Operations group was fully operational and ready to offer electronic publishing services to IMPACT’s clients. The staff to manage and support this group was secured.

FDA 40

FDA Packaging Documentation 40

Druggist

SEPTEMBER 7, 2020

However, it has been documented that when used regularly, tolerance develops rapidly (Vande Griend, Anderson, 2003), within a few days of starting the treatment. Published 2014 Nov 7. Melatonin is a hormone, which is secreted at night in the brain. In the UK melatonin is prescription-only medication (POM). 2014;13:106.

Documentation 94

Documentation 94

European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

FDA 103

FDA Documentation Compounding Pharmaceutical Companies 103

The FDA Law Blog

FEBRUARY 29, 2024

According to documents in the PTO’s Patent Center, Lilly has not yet filed a response. RE 44,599 and RE 44,638 were submitted nearly ten years ago (a point not lost on Gilead as noted below), on September 17, 2014 (Docket Nos. Our second example follows the same pattern as the first example above.

FDA 59

FDA Documentation 59

ISPE

JANUARY 11, 2023

August 2014. 5 It includes cleaning validation master plan, product risk assessment, utility and equipment readiness, analytical method readiness, sampling site selection/grouping, standard operating procedures, validation protocols, execution of validation protocols, personnel training, and the validation documentation package.

Method Validation 52

Method Validation Documentation Packaging Compounding 52

The FDA Law Blog

DECEMBER 11, 2023

OHT-7’s well documented meltdown during the COVID-19 public health emergency should serve as an object lesson. 2, 2014), [link]. [12] Even if MDUFA VI were to allow the hiring of a significant number of new personnel, implementation of the Proposed Rule would begin before those employees arrive. 31, 2023), [link]. [10] 11] Jeffrey N.

FDA 69

FDA Research Laboratories Documentation 69

ISPE

SEPTEMBER 8, 2023

USA The FDA established the Emerging Technology Program (ETP) in 2014 and has actively promoted the program 8. en/documents/other/european-medicines-agencies-network-strategy-2025-protecting-public-health-time-rapid-change_en.pdf 11 European Medicines Agency. 22 June 2023. EMA/321483/2020. 3 July 2020. www.ema.europa.eu/en/documents/other/european-medicines-agencies-network-strategy-2025-protecting-public-health-time-rapid-change_en.pdf

FDA 52

FDA Documentation Dosage Communication 52

ISPE

MARCH 15, 2023

Green Building Council, 2014. 30 July 2014. There is an increase in those issuing a path to net zero design strategy document, which sets out design parameters covering all aspects of a project from initial concept through the commissioning, post-occupancy surveys, and audits. 7 December 2017. Green Building Council.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Published July 2014.

Documentation 52

Documentation FDA Communication Packaging 52

IDStewardship

APRIL 13, 2023

BCPS, BCIDP Article Posted 14 April 2023 In 2014 CDC released the Core Elements of Hospital Antibiotic Stewardship Programs (Core Elements) to help hospitals increase infection cure rates while reducing treatment failures, C. Gauthier, Pharm.D., ” Given that we cannot be everywhere all the time, how can this be demonstrated?

Hospitals 246

Hospitals Documentation Communication Patient Care 246

ISPE

JULY 5, 2023

In 2014, CDER established the Emerging Technology Program (ETP) within its Office of Pharmaceutical Quality to better facilitate the adoption of emerging technologies such as CM. In 2014, CDER created the ETP to support stakeholders in developing and implementing CM. 17 Table 1: Regulatory hurdles and FDA actions.

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

The Thyroid Pharmacist

JULY 14, 2023

10] I initially wrote a guide on LLLT for my clients in my Hashimoto’s Self-Management Program in 2014, before the follow-up study was done, and was concerned that the effects wouldn’t last. Remission of Hashimoto’s thyroiditis in a twelve-year-old girl with thyroid changes documented by ultrasonography. 2010;20(10):1187-1190.

Dosage 98

Dosage FDA Immunization Documentation 98

pharmaphorum

OCTOBER 1, 2021

The debut – raising upwards of £350 million from new shares – is the largest IPO for a UK biotech company since allergy drug specialist Circassia in 2014. It may also use the cash injection for “in-licensing opportunities and potential acquisitions”, according to the document.

Documentation 52

Documentation Vaccines 52

The Checkup by Singlecare

JUNE 14, 2024

Additionally, a 2014 review of studies points to evidence that people with NAFLD are more likely to be deficient in vitamin C, leaving them more prone to inflammation and oxidative stress. The upper limit of intake for vitamin A is 9000 IU daily, but it is important to know that toxicity has been documented with doses over 8000 IU daily.

Immunization 105

Immunization Documentation Compounding Labelling 105

The Digital Apothecary

MAY 11, 2018

My Years as an Assitant Professor Luckily (sarcasm) part of going up for promotion includes creating a document a couple hundred of pages long detailing what you did. So a lot of the past few years are fresh in my mind and by annual activity, reports are useful just to document my experiences.

Hospitals 52

Hospitals Documentation Patient Care 52

pharmaphorum

JANUARY 13, 2023

A daily 20 mg does of atorvastatin – available as a low-cost generic – is the statin of choice for primary prevention, according to the document. It is the second time that NICE has lowered the threshold for statin prescribing, after cutting it from 20% to 10% in 2014.

Documentation 52

Documentation 52

European Pharmaceutical Review

JULY 1, 2022

The PSCI encourages commitment and accountability, as well as documentation.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Documentation 98

European Pharmaceutical Review

DECEMBER 19, 2023

7 The additional substantial economic benefits that flow from room-temperature storability have also been thoroughly documented. This requires the development of technologies to rapidly produce effective, safe, stable vaccines that can be manufactured and distributed quickly. Available from: [link] q=US10821210B2. cited 2023July].

Vaccines 111

Vaccines Communication Immunization Documentation 111